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Intercept, awaiting needed trial data, pulls its NASH drug application in Europe

Intercept’s decision to withdraw an application for obeticholic acid in Europe doesn’t necessarily come as a surprise. Top executives hinted such an outcome was possible on a conference call last month.

In a statement Thursday, the company explained the decision as a consequence of timing. The results Intercept has submitted so far weren’t enough to secure support from European drug regulators, and the company couldn’t stretch the review timeline any further to incorporate new data.

On its face, that means obeticholic acid, or OCA, has now been rejected in the U.S. and won’t get to market anytime soon in Europe — an outcome that seemed unlikely in 2019 when Intercept became the first biotech to report positive results in a Phase 3 trial in NASH. The company has since lost much of its market capitalization and last September laid off a quarter of its workforce to save cash. Its longtime CEO, Mark Pruzanski, stepped aside a year ago. And Intercept shares, which one traded at more than $400 apiece, are now worth less than $16.

Intercept may still have a chance to rebound. Multiple other drugmakers have failed to capitalize on Intercept’s stumbles, as NASH — a liver disease thought to affect millions of Americans — has proven an elusive target. That’s given Intercept time to collect the additional information the FDA has required for a new approval submission.

Those results, which come from a re-analysis of the Phase 3 study REGENERATE, are expected early next year. They’ll include 18-month biopsy results from about 500 more patients than were included in its original filing, as well as more safety data.

Intercept also anticipates soon getting findings from a different Phase 3 study, REVERSE, in NASH patients who have cirrhosis but don’t yet show symptoms.

Those two results, combined, should provide the “long-awaited clarity on the viability of OCA in NASH,” wrote Thomas Smith, an analyst at SVB Leerink, in a note to clients. If they’re positive, Intercept could re-file for approvals in the U.S. and Europe next year.

Intercept shares fell about 9% in early trading Thursday.